Living hinge for athletic brace or support

ABSTRACT

The invention comprises an elastomeric athletic or orthopedic brace, support for a joint complex and is a network of interlinking elastomeric bands that extend radially from a hub member having a section of reduced rigidity to support a joint in tension but provide for controlled hinging about an axis defined through the hub member. In particular, the brace is provided for an ankle.

FIELD OF THE INVENTION

The invention relates to generally to an elastomeric athletic ororthopedic brace or support that includes a hinge system which includesone or more elastomeric supports members that is engineered to deform soas to allow and direct a preferential direction of movement through thesupport member. In particular, the hinge system forms a component in abrace having an external, adjustable network of elastomeric interlinkingsupport bands that radiate out. The hinge is a “living hinge” meaningthat it is an elastomeric hinge that supports the joint at its axis ofmovement, that it self-locales at that pivot point, and that is providesfor an engineered movement of the joint as a result of its material andstructural characteristics.

BACKGROUND OF THE INVENTION

The invention generally provides an athletic or orthopedic brace orsupport, which may include an elastomeric sleeve having fenestrationsmeaning in this instance, areas of reduced support, which may beopenings or which may include an area of a softer or more yieldingmaterial characterized by a lower durometer material. More preferably,the hinge forms a component in a brace comprising an adjustable networkof elastomeric interlinking support bands with or without an underlyingweb of material. In both cases, the brace surrounds and supports one ormore joints so as to provide an external anatomically configuredframework that mimics or augments the effects of the ligaments. In theenvironment of the brace, the invention includes a hinge system that isengineered to allow motion in a controlled manner, so that the supportedjoint may be flexed in a direction that is not harmful but wherepotentially harmful motion is inhibited by the brace.

Thus, the invention relates to one or more central support member(s)that defines an axis of motion. This support member is intermediate afirst brace part on one side of the joint in question and a second bracepart on the other side of the joint. The support member preferablycomprises opposing hub members, such as on the medial and lateral sideof the ankle, knee or elbow joint which members together define an axisabout which a first member of the brace pivots relative to a secondmember of the brace. For most uses, the first brace part or top membercan be a proximal member while the second brace part or bottom membercan be a distal member, and for an exemplary embodiment for use on anankle, the first brace part or top member is a leg member and the secondbrace part or bottom member is a foot member and the brace includes amedial support member or hub (i.e. a support which surrounds preferablyat least 270 degrees, and advantageously, 360 degrees of the medialmalleoli) and similarly, a lateral support member or hub. Together thesehub members include an opening or weakened area in the middle whichoverlays the ankle bones (i.e. malleoli) to define an axis about whichthe ankle hinges and which the brace permits while still inhibitingmovement in other planes, such as torsion or twisting.

Advantageously, the first and second brace members comprise a network ofelastomeric supports, (preferably band members that are longer than theyare wide and wider than they are thick so as to comfortably distributethe tension that they apply to the user) and also includes a pluralityof strut members (once again elastomeric band members) comprising afirst set of struts on the medial side of the ankle brace and a secondset of struts on the lateral side of the ankle. The medial set of strutsradiate outwardly from the medial support or hub and are linked to theperiphery of the brace on the medial side and the lateral set of strutsradial outwardly from the lateral support or hub and are linked to theperiphery of the brace on the lateral side of the brace. The peripherycomprises a cycle of reinforced portions which include a band (againhaving a geometry and dimension so as to optimally apply a tension tothe user which is comfortable in use) which surrounds the proximalportion of the brace and one which surrounds the distal portion of thebrace, and wherein the proximal band or anchor is linked to the distalband or anchor by an anterior band on the top of the brace and aposterior band or bands on the bottom of the brace. Advantageously theanterior band offset from the front of the ankle and the posterior orplanar bans comprises a series of bands on the sole of the brace. Theanterior band can include means for fastening or adjustment, includingfor example, the hook or loop of a Velcro fastening assembly. The matingportion of the fastening means can advantageously be held on straps thatextend from the rear of the brace, such as a medial strap and a lateralstrap which encircle the ankle and which spiral about the ankle so as todirect the tension of the brace around the ankle, and around the brace.

The spaced support members or hubs, pairs of radial struts and theperipheral linked support act to limit the lateral motion (i.e., side toside or torque or twisting) while allowing the hinging of the brace muchin the way that the spokes of a wire spoked wheel or the cables of atension bridge act to support the main body in tension while the mainbody member accepts and transmits compressive forces. In accordance withthis invention, the support member or members are engineered to allowfor preferential deformation of the shape of the support topreferentially allow or direct motion within or at the support member ormembers. More specifically, the support member includes a section ofreduced rigidity, such as a section of reduced volume (including areduced width, thickness or absent length i.e., a discontinuity such asa notch or gap) so as to encourage the deformation of the support at aspecific location or for example, for a ringed band, a defined bucklingor lapping which allows the first and second brace parts to hinge aboutan axis defined by the support member or hub. Alternatively, the sectioncan be a section of material having increased elasticity, such as anarea in which there is a lesser degree of cross-linking. Thus, the braceencourages motion, including rebound or re-coil in the permitteddirection while inhibiting motion that is more likely to have thepotential to harm the joint.

In the exemplary ankle brace, the medial or inside set of struts (i.e.elastomeric bands which act in tension as struts) thus includes one ortwo upwardly extending strut members that join at the bottom to themedial support or hub and on the top to a proximal harm of the bracenetwork and one or two diagonally extending strut members that extendfrom the medial support or hub to a distal band of the brace network.The inside set of struts can also include a posterior set of struts thatjoin to a rear band that encircles the heel of the user, oralternatively, the hub can connect directly to the rear band. Since thebrace preferably is open at the heel and to the rear for entry, itincludes a rear band that circles the heel cut-out and extends alongeach edge of the rear of the brace and joins to the proximal band. Onone side, preferably the lateral side, the rear band extends into astrap, which laps over the medial side of the brace and fastens. such asabout the top of the brace. The outside or lateral set of strutslikewise include a corresponding network of radially extending, strutmembers (i.e., bands), such as one or two upwardly extending membersthat connect the lateral support or hub to the proximal edge and one ortwo diagonally extending strut members that connect the lateral supportor hub to the front edge of the foot member and a downward strut thatconnects the lateral support or hub to the bottom of the heel band and arearward extending strut that connects the hub to the rear portion ofthe rear band which extends into a strap that spiral from inferior tosuperior and across the front of the ankle to close the brace to adesired tightness. This configuration of the brace allows a rear entrybrace which closes around the front in such a way that the closure meansserve primarily for sizing and tightening, and are not subject to thedirect forces that tend to cause closure means to wear out, for example,when the hook and loop of Velcro is tensioned along the direction offastening.

Preferably, the brace further includes a sleeve or web of underlyingelastomeric material which underlies the network of supports (i.e.framework of bands) so as to distribute the forces of the network overthe users skin and to provide a comfortable layer which may includetexturing, such as nibs, notches or perforations so as to increase theproprioceptive aspects of the brace and also to permit the brace to“breath” or to allow sweat to evaporate from under the brace. Likewise,the hinge aspect of the present invention can be used for braces forjoints other than the ankle, including, the knee, ankle, or phalanges.

The hinge system of the invention can be used in braces which are usedprophylactically (for example, allowing sufficient range of motion toallow the brace to be worn during athletic activities without hinderingthe athlete, but which acts to support the joint or joint complex and toinhibit potentially harmful motion) or the brace can be usedtherapeutically (for example, in the aid of healing of a joint or jointcomplex which has suffered some previous injury). The brace hasapplication in all of the joints, including the shoulder, elbow, wrist,hand, thumb, foot, knee, hip and back and the concepts of the presentinvention can be applied to each of these joint complexes, but isillustrated specifically with respect to an ankle brace.

The present invention provides an answer to the issues of injury relatedand prophylactic joint support in the form of a hinged elastomeric bracethat provides for directed and anatomically configured support, as wellas proprioceptive reinforcement for the brace user. The brace of thepresent invention provides an increased PAR as compared to the prior artbracing which is a result of the support framework providing stoplimited vector directed support in addition to or combination withsurface achieved tactile response.

SUMMARY OF THE INVENTION

The brace is in the form of a hinge system which is a component of abrace that may be a sleeve (which can be considered a single unit thatspans the joint or a first part on one side of the joint, and a secondpart on the second side of the joint) and formed from an elasticmaterial in which a more distal portion comprises a loop, which ispreferably a continuous loop, which encircles a portion on one side ofthe joint or joint complex and a more proximal portion that encirclesthe other side of the joint or joint complex. The brace further includesnegative or void areas (i.e. “fenestrations”), such as weakened areas,recesses or apertures that act to re-direct forces through thecomplementary areas which assume the stresses in response to theexistence of the negative area. In further embodiments the sleeve alsoincludes or consists of (meaning there is no web in addition to theframework) a web or framework of stiffer, more rigid, or less elasticsupport members that interconnect with each other and between a proximaland distal anchor, each of which encircle the limb. This web orframework acts to augment the natural ligaments. In a way that providessupport but which limits potentially harmful motion.

The ankle brace which illustrates the present invention includes thefoot portion and the leg portion which join together at the ankle joint,and is comprised of an interrupted web (in this case meaning a flat, andpotentially homogeneous cast or molded sheet) of elastomeric material inwhich the interruptions or openings together with the materialcharacteristics of the elastomer define the manner in which the bracefunctions. In particular, the material forming the foot portion and theleg portion are separated by the heel opening and the TFT opening whichallow the foot portion and the heel portion to form a joint therebetween, and to accommodate movement at the ankle joint withoutunnecessary material or bunching. This is a particular advantage for asoft brace that is worn underneath a shoe, other athletic footwear, or ashin guard. In addition, the combination of the malleoli openings andthe two openings at the medial and lateral surfaces of the plantarcovering of the foot portion of the brace act so as to provide directionas to resistance of force sustained within the web of material that isdefined by the combination of the openings. Moreover, these openings areengineered to permit a relative pivotal motion between the foot, and legparts, and this hinge system is formed by ringed support member (i.e.,bands) that from a complete 360° circuit (optionally in some embodimentsof the hinge member minus a small section such as 1-20°, and preferably2-10°, and most preferably 3-7°), which may advantageously be a circle,oval, or ellipse, but which also form a linear support, such as aquadrangle, or a hexagon or geometric shape.

Thus, the brace of the current invention is designed to allow as muchsafe freedom of movement to the wearer as possible, but to provideresistance to movement that could be harmful. In particular, the deviceis intended to inhibit inversion in plantar flexion (and to helpstabilize the syndesmotic ligament) so as to avoid “rolling” an ankle.The brace is intended to provide external support tantamount to externalligaments and or fascia, that reinforces in proper places but whichrelieves pressure where it is needed. Thus, the device acts in tensionand compression to buttress the syndesmotic ligament at the top, and inthe cross-configuration to buttress the ATFL (anterior tibiofibularligament), and the CFL (calcaneal fibular ligament), with a medial webmember that buttresses the deltoid ligament. In addition, theelastomeric nature of the brace material, and in particular of the hingesystem, coupled with the form can act to provide energy re-balance tothe wearer, where the kinetic energy is re-circulated or re-coiled tothe user, while inhibiting potentially dangerous forces applied to thejoint complex. The material also provides proprioceptive feed-back tothe user and the elasticity and/or stickiness of the material helps toremind the user to maintain tone. It is preferable that the material is“alive” or slightly sticky to the skin of the wearer. A desirable levelof stickiness would be the feel of slightly under-cured natural latex,or a material that has been exposed and allowed to dry to a solution ofsugar-water, or something less adhesive than a traditional band-aid or alight masking tape. Acceptable values measured according to ASTM,D3330D/D3330M, Test Method F at 90°, for peel adhesion of pressuresensitive tape, would be 0.0005-50 N/100 mm, preferable 0.5-30 N/100 mm,and most preferably 0.2-25 N/100 mm.

In a further embodiment of the invention, additional, and optionallyexternal adjustable struts are provided to provide joint stabilityagainst typical directions of ligament strain. Specifically, as relatesto the brace of the present invention in use for ankle support, thestruts are provided as one or more additional add-on elastomeric strapmembers that extend diagonally across the lateral or medial aspect ofthe brace, and optionally including support over the malleoli to provideone or more line of support in two more or less orthogonal directionsextending inferiorly to superiorly and posteriorly to anteriorlyrespectively and optionally running diagonally over the anterior surfaceof the ankle joint. In addition, depending on the indication, thesupports can include footplates of wedged footplate to change theplantar plane of the foot. Since these straps can be added to the braceto supplement the brace itself, they can be provided with more or lessstretch to provide for more or less support to the joint.Advantageously, the straps have easy attachment means, such as a theillustrated Velcro attachment or a puck and grommet mechanism, in whichthe straps include spaced apart pucks that can be pushed into a retainedrelationship with the grommet, and that can be popped out of engagementby pulling outward on the extensions. This aspect of the invention isillustrated in various embodiments in FIGS. 13-34.

in an adjustable version, the brace is in the form of a sleeve (whichcan be considered a single unit) that spans the joint or a first part onone side of the joint which comprises a flat web or band of materialthat is wrapped around a body on one side of the joint and is closed byclosure means which provide for adjustability and for the ability toprovide directed tensioning. The sleeve also includes a second part onthe second side of the joint and formed from a continuous (i.e.integral) elastic material where a more distal portion comprises a loop,which is preferably a continuous loop (and here it is envisioned thatthis loop could also be formed by closing a flat web to form a circle),which encircles a portion on one side of the joint or joint complex anda more proximal portion that encircles the other side of the joint orjoint complex.

The leg portion of the brace includes a proximal opening that encirclesthe lower leg sufficiently above the lateral and medial malleoli inorder to provide a suitable proximal anchor on the leg of the user. Asecond distal anchor is joined at the foot opening. This portion of thebrace also forms a continuous loop, but advantageously is openable, forexample, to the rear, or preferably slightly lateral to the Achillestendon, for entry into the brace, and also to provide adjustability inthis portion of the brace. In a further embodiment, the first and secondanchors are stiffer more rigid elements, formed for example, of a higherdurometer material, (e.g. 85+/−30 and preferably 70+/−10, and mostpreferable 70+/−5 durometer on the Shore A scale.) The anchors areinterconnected by supports or struts in the form of strips, or bandswhich have a much longer length than width more than 5×, and preferablymore than 10× but where the width is between ⅛ to ½ inch and the lengthsare from ½ to 15 inches depending on whether the length is taken for asingle segment, which may be as short as ½ inch or as long as 10 inchesextending along a line, or for an aggregate of a number of segments) ofthe same or similar material. The supports interconnect to form aframework or network of ligament complementary support which aids thejoint and inhibits “harmful” motion while freely permitting acceptablemotion. These supports can have a similar durometer as set forth aboveor one that is slightly lower (i.e. by 1-5 units on the shore A scale).

Various closure mechanisms can be used at the anchor juncture(s),including straps, bands, webs, and cables having a closure means thatmates with a corresponding closure means on the lateral side of thesleeve. These closure means could include buttons, hooks, latches,ratchet mechanisms, post and pin, groove and slide, hook and loop, postand loop, Velcro, cables, and zippers to name a few. The presentinvention also provides novel mechanisms for closure of a soft and/orelastomeric brace.

The brace further includes negative or void areas, such as weakenedareas), recesses or apertures that act to re-direct forces through thecomplementary areas which assume the stresses in response to theexistence of the negative area. The weakened areas can comprisecomplimentary webs of softer, more yielding, lower durometer material,e.g. having a durometer of 35+/−10, and preferably 45+/−5, on the ShoreA scale. This material may also include perforations, such as pores orholes of 0.0001-0.05 inch diameter, to allow for the evaporation ofperspiration. These pores may also affect the softness of the material.

In further embodiments, the distal and proximal anchors are connectedstructurally by struts or supports which are different than the basicsleeve webbing (i.e., by bands, straps, laces, or cables which are lesselastic than the remainder of the brace,) so as to transmit forcesdirectly between them and between the distal and proximal anchors bymeans of supports which can permit desired motion which is deemed to bewithin a healthy range of motion, but restrain undesired motion, whichwould be potentially harmful to a vulnerable joint. The higher stiffness(or lower elasticity or resistance to stretch) can be effected by anumber of methods, including a change in material, a change in materialcharacteristics, including cross-linking or durometer which can becaused by the manufacturing method or by the ingredients, or a change inthe geometry, including thicker or wider or higher volume of material soas to direct, inhibit or manipulate forces transmitted to the affectedjoint during use. Preferably these supports extend radially from themalleoli supports much like a hub includes spokes in a spoke wheel, andthe supports are linked to a peripheral support system which includesthe proximal band, the rear band, the plantar supports, the distal band(which may include a v-feature to accommodate various foot widths andshapes) and an anterior support which may be offset from the medialplane in order to provide for a more comfortable fit.

Finally, the brace can include pockets for sensors including motion ofpressure sensors, including for example, transducers or accelerometers,that can be used for kinetic assessment such as standard gait analysis,or athletic training. Alternatively, these sensors can be integrated orembedded into the brace.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front perspective view of the right ankle brace inaccordance with the present invention shown on the ankle of a user;

FIG. 2 is a top medial perspective view of the medial side of the anklebrace of FIG. 1;

FIG. 3 is a top lateral perspective view the lateral side of the anklebrace of FIG. 1;

FIG. 4 is bottom medial perspective view of the ankle brace of FIG. 1;

FIG. 5 is medial side view of the brace of FIG. 1;

FIG. 6 is a lateral side view of the brace of FIG. 1;

FIG. 7 is a front view of the ankle brace of FIG. 1;

FIG. 8 is a top view of the ankle brace of FIG. 1;

FIG. 9 is a bottom view of the brace of FIG. 1;

FIG. 10 is a detail of the lateral side of the brae of the presentinvention showing the reduced volume hinge;

FIG. 11 is an edge-on view of the lateral malleoli support showing thereduced volume section of the support;

FIG. 12 is a detail of the hinge member of medial malleoli support;

FIG. 13 is a top perspective view of a first embodiment of the presentinvention further including an additional supplemental lateral support;

FIG. 14 is a lateral view of the embodiment of FIG. 13;

FIG. 15 is a front view of the embodiment of the brace shown in FIG. 13;

FIG. 16 is a top perspective lateral view of a second embodiment of thepresent invention further including the additional supplemental lateralsupport;

FIG. 17 is a medial view of the embodiment of FIG. 16;

FIG. 18 is a front view of the embodiment of the brace shown in FIG. 16;

FIG. 19 is a bottom perspective lateral view of a third embodiment ofthe present invention further including the additional supplementalmedial support and wedged footplate;

FIG. 20 is a lateral side view of the embodiment of FIG. 19;

FIG. 21 is a medial side view of the embodiment of FIG. 19;

FIG. 22 is a front view of the embodiment of FIG. 19;

FIG. 23 is a rear view of the embodiment of FIG. 19;

FIG. 24 is a bottom view of the embodiment of FIG. 19;

FIG. 25 is a top perspective lateral view of a fourth embodiment of thepresent invention further including the additional supplemental lateralsupport;

FIG. 26 is a medial view of the embodiment of FIG. 25;

FIG. 27 is a medial view of the embodiment of FIG. 25; and

FIG. 28 is a front view of the embodiment of the brace shown in FIG. 25.

DETAILED DESCRIPTION OF THE INVENTION

The present invention is illustrated as a component of an ankle brace,but has been previously stated, could comprise a component of a bracefor a different joint or even of a brace other than the illustratedbrace. In the ankle brace 10 that is shown, a first part or more distalportion 12 encircles the mid-foot of the user 14 and a second part ormore proximal portion 30 encircles the lower leg of the user. The braceis provided in a right version and a left version which are mirrorimages of each other, and also can be provided in multiple sizes,including for example small and large, or pediatric, ladies and men. Thebrace is illustrated as a right ankle brace and the left ankle brace isa mirror image of the right ankle brace shown.

The brace includes a web 22 of flat elastomeric compound or material,which, if opened, would form a flat sheet of relatively uniform oruniform thickness and comprised of a homogenous composition, whichoptionally includes reinforcing material such as fiber, but which ispreferably not a mesh, woven or non-woven fabric in this configuration.The web can form a sleeve 23 comprising the web members of the footportion 12 and the leg portion 30, and which underlays the interlinkingnetwork of relatively more rigid (i.e. compared to the sleeve material)bands of elastomeric support. The foot portion 12 has a distal opening16 that is configured to snugly surround the user's foot, atapproximately the neck of the fifth metatarsal through the plantarsurface to the middle of the first metatarsal and arching proximallytoward the tibial fibular talar joint over the dorsal surface of thefoot. At the other end, the foot portion 12 ends on the plantar sideposterior to the end of the medial arch in a heel opening 18 suitable toexpose the fat pad of the heel (approximately ½ of the way posteriortoward the heel end of the calcaneus) on the posterior side, and belowthe insertion of the gastrocnemius into the Achilles tendon as itextends upward on the leg to form the bottom boundary of the leg portionof the brace. The foot portion 12 ends on the anterior side of the ankleat the “eye of the ankle”, i.e. on the superficial aspect of theanterior ankle at the joint of the tibia/fibula/talus (or the “TFT”joint). The foot portion 12 includes a web of material 22 (preferablymolded or cast) that covers an area corresponding to the cuneiforms andthe cuboid bone and the navicular bone. On the medial and lateral sidesof the brace, the foot portion runs diagonally between the anterior andposterior openings where it joins the leg, portion 30 which surroundsthe bottom portion of the leg or the vertical portion of the ankleapproximately ⅓ of the way up the lower leg, and below the bellies ofthe distal aspect of the gastrocnemius.

The leg portion 30 of the brace includes a proximal opening 32 thatencircles the lower leg sufficiently above the lateral and medialmalleoli in order to provide a suitable anchor on the leg of the userfor the forces applied by and to the brace. This portion of the bracealso forms a continuous loop when it is closed.

In addition to the previously described openings including the twoterminal openings there are several other functional negative areas or“fenestrations” (used herein to mean areas of decreased resistance,including for example through openings, as well as areas in which thereare material changes, such as a more stretchy or less cross-linked oreven a thinner web of material) in the brace. The two terminal openingsinclude the first or distal most 16, having an edge that runs across themid-foot on the plantar side, and arching back toward the TFT joint overthe top of the foot to the proximal aspect of the metatarsals: and thesecond or proximal most opening 32 forming a roughly circular openingwhich encircles the lower leg about 1.5-3.5, and preferably 2-2.5 inchesabove the malleoli or a third of the way up the lower leg and below thebelly of the gastrocnemius.

The functional openings include the opening at the heel 18, which isopen to or excludes coverage of a significant portion (i.e. 75% or moreor all of) of the surface area of the heel pad, having an edge just infront of the medial process of the calcaneal tuberosity, and on the legportion of the brace just above the insertion of the Achilles Tendonsuperior to the calcaneal tuberosity. Further, the brace includes twoopenings that correspond 1) to the medial malleolus 40 and 2) to thelateral malleoli 42, in the present embodiment, on the medial side, themalleoli openings 40, 42 are roughly circular or oval in shape boundedby support bands which form a part of the hinge system as are furtherdescribed below. These openings approximate a size slightly larger thanan average size of a malleolus. The distal opening ends proximally infront of the tuberosity of the fifth metatarsal, and distally roughly0.5-1 inch behind the terminal opening of the foot portion at the neckof the fifth metatarsal.

The brace includes the foot portion 12 and the leg portion 30 whichseamlessly join together at the ankle joint to form one integratedsurface, and is comprised of a web of elastomeric material having aninterlinking network 15 of support bands or struts in which thecombination of the web, the network of bands of external supportstogether with the material characteristics of the material define themanner in which the brace functions. In particular, the sleeves formingthe foot portion 12 and the leg portion 30 are separated by the heelopening 18 and the network of support bands 15 include a pair of openmalleoli supports 40, 42 including radially extending struts 44 whichallow the foot portion and the heel portion to form a hinged joint 50there between, and to accommodate movement at the ankle joint withoutunnecessary material or bunching. This is a particular advantage for asoft brace that is worn underneath a shoe, other athletic footwear, or ashin guard. In addition, the combination of the malleoli supports 40, 42and the two openings at the medial and lateral surfaces formed betweenthe medial and lateral support network and of the plantar covering 52 ofthe foot portion of the brace act so as to provide direction as toresistance of force sustained within the web of material that is definedby the combination of the openings. Further the malleoli supportsinclude a mechanism to cause an engineered preferential deformation,which results in a hinging of the associated parts of the brace, Thus,the brace of the current invention is designed to allow as much safefreedom of movement to the wearer as possible, but to provide resistanceto movement that could be harmful, in particular, the device is intendedto inhibit inversion in plantar flexion (and to help stabilize thesyndesmotic ligament) so as to avoid “rolling” an ankle. The brace isintended to provide external support tantamount to external ligamentsand or fascia, that reinforces in proper places but which relievespressure where it is needed. Thus, the device acts in tension andcompression, to buttress the syndesmotic ligament at the top, and in thecross-configuration to buttress the ATFL (anterior tibiofibularligament), and the CFL (calcaneal fibular ligament), with a medial webmember that buttresses the deltoid ligament. In addition, theelastomeric nature of the brace material, coupled with the form can actto provide energy re-balance to the wearer, where the kinetic energycreated in a muscular exertion of the user is re-circulated or re-coiledto the user, while inhibiting potentially dangerous forces applied tothe joint complex. The “spring” that results, and the resilient contactof the brace with the surface of the ankle, also provides aproprioceptive feel to the user that helps to protect the ankle joint.

It is a further advantage in some instances to provide the brace withsupplemental support means that can be adjusted to suit a particularuser. This embodiment is also illustrates a rear opening aspect of theinvention in which the leg portion has an opening 115 between the medialand lateral portions that preferably overlap or abut each other toencircle the leg, and from which straps 108 extends to allow forclosing, tightening or tensioning, and which also include closure means,in this illustrations hook and loop or Velcro fastening means 109. It isof advantage that the support means act to inhibit stress to thesyndesmotic ligament, to the TFTL, and to the TCL. Thus, the supportmeans advantageously extend from the plantar supports covering (oroptional footplate) diagonally upward across the anterior hinge of theankle in the vicinity of the cuboid and navicular bones, and possiblyeven to a further support member or anchor at the proximal end of thelower leg portion of the brace. These means can include straps, laces orcable members that are designed so as to provide for adjustable degreesof tensioning, as well as adjustable directions of tensioning to allowthe wearer to customize the feel and size. The device acts in tensionand compression to buttress the syndesmotic ligament at the top, and inthe cross configuration to buttress the ATFL (anterior tibiofibularligament), and the CFL (calcaneal fibular ligament), with a medial webmember that buttresses the deltoid ligament.

The present invention is designed to provide some syndesmosis stabilityabove the malleoli. In a further adjustable embodiment, it illustratedwith a rear entry, i.e. open toward the posterior portion of the leg,but with an adjustable closure fixation point more anterior oranterolateral, (preferably not medial), with tension from posteromedialto lateral so as to pull the fibula anteriorly to help with syndesmosisstability and ankle. The optional superior band, is comprised of areasonably high tensile strength to protect the syndesmosis. The braceis designed to provide a definite end to plantar flexion and inversionand also some level of protection on the syndesmosis.

It is envisioned that the brace comprises an interlinking network ofsupports 120 or elastomeric bands such as struts built into the lateraland medial side of the brace on the lateral side of the brace radiatingoutward from the medial 40 and lateral 42 malleolus supports andextending between the foot portion 12 and the superior portion of theleg support 30. On each of the lateral side and the medial side thesupports or struts 120 form a first portion 121 to support the foot anda second portion 122 to support the leg of the user. The first portionand the second portion are hinged at the ankle joint at an axis ofrotation that permits the ankle to hinge about the line 50. This hingeis formed by the provision of a medial hub at the medal malleolussupport 40 and the lateral malleolus support 42. The first portion isjoined to a distal band 125 that encircles the foot and a proximal band127 that encircles the leg. The network is connected to these anchors,which act to support the struts in tension and to allow the interlinkingnetwork 10 actually support the ankle in movement, like the spokes of awire spoke wheel or a cable bridge. The struts comprise a series ofstruts which include one a lower lateral strut 131 connecting themalleolus support 42 to the band 133 and a lateral posterior strut 135connecting the lateral malleolus support 42 to the extension of the heelband 133 defining the heel opening which in this case forms a closurestrap 137. The struts also include two superior lateral struts 139 whichconnect the lateral malleolus support 42 to the top band 132 which formthe top anchor for the leg portion of the brace. In addition, there aretwo anterior struts 138 which connect the lateral malleolus support 42to the distal foot band that forms the foot anchor 134. Preferably,these two anterior struts form a gusset 140 or v-shaped link to the footband 134, which is disconnected between them distally so as to allow thefoot band to have a degree of give to accommodate various foot shapesand to allow the brace to be put on.

On the medial side, there is a corresponding first foot portion ofinterlinking bands and a second leg portion of interlinking bands orstruts which connect the medial malleolus support (i.e. a ring which iscircular or preferably oval to encourage hinging that surrounds themalleolus). The medial struts include a pair of anterior supports 152that join the malleolus support 42 to the foot anchor 125 and a pair ofsuperior struts 154 that join the malleolus support 42 to the proximalband 12 which forms the leg anchor for the interlinking network ofbands. At the rearward portion of the interlinking network, the medialstruts join directly into the medial heel band member 136, which joinswith the proximal anchor and extends into the medial strap which closesthe brace at the top of the brace. The lateral strap and the medialstrap include closure means 109, such as hook and loop that join with amating closure means 109 on the leg portion of the brace. The brace isdesigned so that the hook and loop avoid tension in the line offastening. Thus, the hook and loop can be used to size and tension thebrace, but resist the problems often encountered with this type offastening means, such as loosening, opening or wear.

These struts 120 should have a definite endpoint at say 90-110% ofphysiological plantar flexion/inversion before easing to a firm stop atwhich point there is recoil. The struts are band members which are from2-10× (and preferably from 3-8×, and most preferably from 4-6×) as wideas they are thick. The basic sleeve of the brace is intended to be verytight on the user with a low tensile strength and durometer so that itmolds well to the ankle. The struts have a high tensile strength thateases to a firm end-point before recoiling. This is advantageouslyaccomplished by providing elements (for example such as one or morefibers, cable or bands that are optionally sinusoidally placed) thathave a high resistance to stretch embedded within or carried on theelastomeric sleeve member. This brace acts in tension rather as abuttress as in the prior art.

In addition, tensioning or closure mechanisms permit the wearer to pullthrough them and get a feel of tension, which provides a reassuring feelto the wearer. This tension is set such that it could result in a veryhigh tensile strength at the end of range of range so that it can bereally quite stiff within a range that is totally safe for the user.Optional closure mechanisms include various mechanisms, such as Velcro,watch strap level backs closure, hook and eye, pin and post, buttons,zippers, cables, laces to name a few. One advantageous closure is awatch strap type closure with a pulley at sinus tarsi level to retainthe tensioning bands in an anatomical position, and having tensioningposts protected with a hinged door on a button at the fibula for extrasecurity. Also, the tensioning mechanism can include a winding mechanismthat translates the rotation of a tensioning dial member to thetensioning strap in order to increase the tension provided by thetensioning strap.

The leg portion 30 of the brace includes a proximal opening 32 thatencircles the lower leg sufficiently above the lateral and medialmalleoli in order to provide a suitable anchor on the leg of the user.This portion of the brace is open to from a planar web 33 (i.e, a flatband) that can be closed to form a continuous loop about the lower leg.The web 33 includes one or more extension 35 that can be a strap or bandof varying thickness and which is of a length preferably so that the legportion 30 fully encircles the lower leg and that the strap, band orcable 35 that extends from a first side of the web 33 can be pulled to adesired tension and secured by means of closure means 109 on the strapor medial side to mating closure means on the lateral side of the web33. The embodiment shown includes an upper strap 35 on the medial sideand a lower strap 37 on the lateral side which spirals upward about theleg portion of the brace. Various closure mechanisms can be used at thisjuncture, including straps, bands, webs, and cables having a closuremeans, that mate with a corresponding closure means on the lateral sideof the sleeve.

The superior band 35 is integral with the top (i.e., the superior edge)of the leg portion 30 of the brace and at least in part, defines thesize and shape of the proximal opening 32 that encircles the lower leg.The superior band 35 includes a closure mechanism that mates with amember on the band or on the brace body or on an attachment or strap onthe brace to allow the closure of the brace, as well as sizing andtensioning as is desirable. The brace also includes a posterior band 37which closes the rear of the leg portion 30 closer to the ground andwhich can overlap from the medial to lateral side as shown or from thelateral to medial side. The posterior band 37 also includes a closuremechanism. which cooperates with a mating member on the brace.

The brace is shown with a series of plantar supports 150, which connectthe heel band and the distal foot band that forms the front anchor.Alternatively, these supports may instead be comprised of a plantar footplate which may be thicker on one side than the other to change theangle of the foot.

Preferably when closed the rear opening of the brace 115 starts at 6:00o'clock and extends laterally. This avoids the overlap occurringdirectly posterior to the Achilles tendon, which could cause aggravationwith running, jumping or use of the ankle joint over time. The medialflap of the leg portion is pulled counterclockwise toward the lateralflap which tends to thin the material our slightly (depending on thePoisson's ratio) and resulting in less thickness and a lower profile.Optimally the overlap in the sulcus with the lateral flap is at about4:30-5:00 o'clock (relative to the anterior medial line). The lateralflap is thinned down near the slit to 1.5−2+/−0.5 mm in thickness. Thestrap and material are designed so that a short distance pull creates arelatively large amount of stress. The placement of the mating lateralclosure members is thus dictated on the configuration and materialchoices so that multiple locations close together results in a wideselection of resulting tensions and sizes, and allowing the user asignificant range of tension within a small range of pull.

The pulling takes the posterior flap to 5:00 o'clock post tensioning.This allows about 90° of workable circumference for placement of thelateral closure means. Preferably, the closure means are low profile andwill not aggravate the user. The bands coming off the medial flap can berelatively short and thus result in good tensioning reproducibility andalso for a significant amount of tensioning with a relatively stiffelastomer. Preferably the bands originate from a hard polymer, which isembedded into the end of the sleeve to provide increased durability anda more even pull. The bands can taper in height, taller at the origin,and thinner at the insertion (i.e. the location of the male closure) tofurther distribute the stress. There is optionally a pull connected tothe male closure member, such as a stiff polymer or cloth which acts asa handle for the user during assembly and which will lay flat when theclosure means is assembled.

Also the brace may be provided as an adjustable brace with a rear entryand closure means that allow sizing of the open portion. For example, itis advantageous to provide an open loop for the leg portion which can betailored to a desired size, and which can even be re tailored at a laterpoint. The anatomic location of the closure mechanism is important, andideally, this is at the posterolateral aspect of the ankle joint; housedbetween the Achilles and distal fibula. This minimizes the interferencewith many athletes' function as well as minimizes general interferenceincurred during gait, again, depending on the mechanism of choice.Alternatively, the closure mechanism can be located on the medial sidewith the tensioning means (or straps) pulling in the direction of thestruts laterally. Advantageously, the tensioning means provides for ½ to1 centimeters of adjustability, (in particular if the brace is providedin three sizes), depending on the material of the tensioning means andthe size range for which the brace is intended.

In addition, in a further embodiment, the brace is illustrated asincluding a framework of a stiffer (i,e. higher durometer material ofapproximately 75 durometer +/−15, preferably +/−10 and most preferably+/−5 on the Shore A scale. This framework 300 includes a proximalanchor, which encircles the upper leg and in this case includes a strapwhich engages a closure mechanism on the front of the brace. Theproximal anchor is a band and forms a flat continuous (i.e. looping backon itself) ring 35 of relatively narrow width and constant thickness andwhich circles the foot. Advantageously, the ring also includes at leastone, but optionally more, (i.e. two three, four or more), v-shaped (orother shape which include a wider opening and a tapering portion whichresists but will allow for expansion of the circumference of the ring)gusset which allows the proximal anchor to expand without losing itsfunction as an anchor in order to allow for size variations of thewearer. The framework also includes an opening 42, 40 on each of thelateral and the medial sides, preferably oval as previously described,to accommodate the malleoli. Struts extend from the proximal anchor tothe malleoli openings. Further struts extend upward from the malleoliopenings to the proximal anchor to complete the circuit between thedistal anchor and the proximal anchor. This brace also includes a lowerstrap 37, which wraps the ankle at a lower position and from the lateralto the medial side and fasten at a hook and loop (i.e. Velcro) on thefront of the brace 109. This area is stiffer and helps to support theanterior portion of the brace framework. The framework front supportforms a base for the leg portion of the closure mechanism, and a rearmember 136 frames the heel opening and is linked to the rest of thebrace through links to the malleoli openings. The fenestrations in thiscase, are actually areas of integrated softer material, for examplehaving a durometer of 40+/−10, and preferably +/−5 on the Shore A scale.This material is a relatively soft sheet of elastomeric material, with auniform thickness from surface to surface, which is slightly sticky tothe touch, as can be formed by injection molding or by casting at alower cross-linking. This softer portion of the sleeve can also includeperforations to allow for perspiration, or can include texturing to thesurface for proprioceptive reasons. The web portion at the gusset may beadvantageously strengthened, for example by eliminating the perforationsin the remainder of the web in order to provide for greater strengthhere since the front of the network is open from the network to providefor greater fit.

The brace is made, for example by molding such as injection or transfermolding, liquid silicone molding or reaction in mold casting, abio-compatible elastomer from a material of suitable durometer toprovide the desired fit, and elastomeric characteristics. The bracepreferably is made of a material that exhibits equal stretch in at leasttwo dimensions (i.e. the X, Y directions). This material can be mademore resistant to provide further support, for example of thesyndesmotic ligament, by various means, including the additional ofsupports or struts which might be provided by an integral (samematerial) thickening of the brace in a defined area, or by changes inthe material itself, such as higher rate of cure or cross-linking or theaddition of other materials such as reinforcing fibers or the use of asecond elastomeric material having greater resistance to an appliedforce, like a higher durometer or Young's modulus or modulus ofelasticity, and which could be embedded in the brace, co-molded, oradhered to the inside or outside of the brace. The brace is designed toallow motion with a limited end-point; to encourage the recoil of energyand to allow for the potential prevention of harmful forces, i.e. thebrace permits motion that is sate within a defined range, but inhibitsabnormal or dangerous motion.

The brace forms a two part sleeve which is in substantial contact withthe skin of the user between the two terminal ends of the brace. Thus,in the first embodiments, while there are fenestrations or openings inthe brace, the remaining web occupies at least 40%, and preferably atleast 50%, and even more preferably at least 60% or 75% of the areadefined by the outline of the brace. In the embodiments having a morerigid framework and fenestrations with a softer web of material theseratios are reversed. The inferior surface may advantageously include amesh, surface treatment or textured finish to increase the breathabilityand to prevent slippage.

In addition, the material is intended for a particular tactileexperience at the surface of the skin of the wearer so as to provide aproprioceptive reminder to the wearer of the type that has been found tohelp inhibit ankle sprains. It is preferable that the brace has aslightly tacky feel at the skin interface. Thus, the brace providesbio-feedback to alert the stabilized joint so that it acts to inhibitundesired motion within that joint. In further embodiments, the bracemay be put on wet, or over an inner sleeve that helps to enhance thetactile experience, such as including a roughly textured surface havinga pattern of bumps, ridges, dimples, cross-hatching or protrusions.

The brace of the present invention can be used in a variety of joints.While the present invention can be used for hinged joints it ispreferably for use in joint complexes, so that for example the “ankle”brace actually is intended to stabilize the ankle, subtalar andtalonavicular joints, and the concepts set forth herein can be useful insupport of other joints, including for example those located at thewrist, the elbow, the shoulder, the knee, and the fingers.

The present invention also has application for treatment of plantarfasciitis, medial and lateral (elbow) epicondylitis, toe andfinger/thumb synovitis. A particular advantage of the present inventionis that the brace is designed to “stretch” to a defined endpoint andthat an effective “stop” is reached by a tension in member that actslike an elastomeric“ligament” placement. This can be provided by achange in structure of the brace, such as increased volume of materialdesigned to limit the stretch, a different material characteristics,such as a higher degree of cross-linking, or change in materialincluding for example, a cohered portion along a lateral edge, or anadhered portion along a top or bottom surface (including fabric whichcould be woven, and which could serve additional purposes, such as skininterface, bacterial or fungal control or odor control), or embeddedmaterials, such as fibers or wires which exhibit relatively littlestretch and are configured to provide a limit to a range of stretch at agiven stop point.

The invention relates generally to a molded elastomeric sleeve of abiocompatible material having a defined hardness and elasticity, shapeand configuration in three dimensions (adapted to the anatomy of ahypothetical user). For the ankle this means a brace configured to endon the foot at the neck of the fifth metatarsal and on the lower legbelow the belly of the gastrocnemius, and having an opening at the heelcup and at the eye of the ankle joint, at the medial and lateralmalleoli, and at the navicular bone and optionally including additionalsupport of additional material or a stronger or less elastomericmaterial on the lateral side which resists a force applied to the anklein inversion, including, for example, an integral support or attachmentsuch as a tension strap positioned anterolaterally to simulate thereaction of the ATFL for more anterolateral stability where there is asupport for syndesmotic stability, and one for ankle stability.

The basic sleeve of the brace is intended to be very tight on the userwith a low tensile strength and durometer so that it molds well to theankle. The material of the brace is ideally an elastomer, including forexample, a thermoplastic elastomer having a Shore A hardness of 2-50 at10 sec when measured in accordance with ASTM D2240, and a tensile breakat stretch of 2-6 MPa at 23° C. using Die C2 hour when measured inaccordance with ASTM D412, tensile stress of 0.08 to 0.8 MPa at strain100% and 0.2 to 1.5 MPa at 300% at 23° C. using Die C2 hour whenmeasured in accordance with ASTM D412, and an Elongation at break of800-1200% at 23° C. using Die C2 hour when measured in accordance withASTM D414, a tear strength of 7.5-20 kN/m when measured in accordancewith ASTM D624, and a compression set of 5-30% at 23° C. and at Time79200 sec when measured in accordance with ASTM D395. Thermoplasticelastomers are suitable materials, with material sold under thetrademarks Versaflex CL30, and CL2000X from PolyOne being preferablematerials, alone, or compounded with additional materials, such as othercross-linking agents, additional elastomers to achieve materialcharacteristics, reinforcing fibers and fillers, antimicrobial agents,colorants, and fragrances.

The brace in accordance with the invention includes struts laminated oradhered to the outer or inner surface or embedded within the sleevemember, and which have a high tensile strength that eases to a firmend-point before recoiling. This is advantageously accomplished byproviding elements (for example such as one or more fibers, cables orbands that are optionally sinusoidally placed) that have a highresistance to stretch embedded within or carried on the elastomericsleeve member. This brace acts in tension rather as a buttress as in theprior art. The brace could further include a fabric backing over anentire surface or over portions of surface in order to control thedirections of resistance including a weave such as a bias weave fabric,which limits the stretch to one axis and inhibits the stretch along theother two axes.

The through thickness of the sleeve will depend on the material andelasticity but is preferably “low profile” meaning that it can be worn,optionally with socks, under a user's pre-owned shoe, meaning that itdoes not require a different size than is worn without the brace.Preferably the thickness would be form 2-to-10 mm, with about 5-8 mm onthe lateral side and such that the brace still fits into the shoe and iscutout to go around the bony eminences. The medial side does not requirethe same resistance and could be 3-4 mm.

As designed, the brace optionally includes a self-formed (meaning thatthe foot plate is only loosely defined by an area of increased thicknessor hardness, and that the wearer's foot acts to define the shape of thefootplate in use) foot plate which contours around the heel moredistally around the base of the fifth, so as to improve ST(sustentaculum/talar) joint stability. Alternatively, the footplatecould be integral with the remainder of the brace, but could be moredefinitely defined, for example, by formation of a different, andpotentially stiffer, or harder material. Thus, the foot plate couldoptionally be provided in a different material, for example a harder, orless stretchy material or this could be accomplished using a differentconfiguration. Also, the footplate could optionally be thicker by 0.5-2mm on the lateral side for approximately the length of the foot plate orat least 50% of the length and approximately ⅕ to ⅓ of the width to biasthe foot to the outside and in order to promote control the tension onthe syndesmotic ligament.

The brace is intended to last at least one season of intermediate levelof non-professional use (i.e. 2-3 times per week), which is based onusage on the idea that the running shoes need to be changed every 300 orso miles, which is approximately 7-8 miles per week in a 9 month soccerseason, or alternatively for one month of heavy use, and wherein thelimiting factors include the continued support and configurationintegrity, odor-free characteristics, and stickiness or tack to providefor the proprioceptive reinforcement.

The invention relates to an ankle brace for a hypothetical user having aleg including an ankle joint complex extending from below agastrocnemius at the proximal side to behind the neck of a fifthmetatarsal on the distal side, the brace comprising a sleeve formed froma sheet of biocompatible elastomeric material having a through thicknessof from 1 to 7 mm, and the brace has a first portion which is a webformed from the sheet of the biocompatible elastomeric material whichforms a first continuous loop about a first axis and a second portionwhich is a web formed from the sheet of the biocompatible elastomericmaterial that forms a second continuous loop about a second axis; andthe first portion of the web having a proximal end which includes a topopening sized to fit below the belly of the gastrocnemius of thehypothetical user and the distal end of the first portion beingconnected to the proximal end of the second portion at a conjunction ofthe first portion and the second portion, and the distal portion of thesecond portion including a bottom opening sized to fit posterior to theneck of the fifth metatarsal of the hypothetical user; and the webincluding at least a first fenestration at the conjunction of the firstand the second portions which is configured such that the first axis andthe second axis are not the same.

It also relates to the previously described ankle brace as set forthabove wherein the fenestration is a through hole and wherein thefenestration is an area of decreased resistance in the web and whereinthe first portion of the web includes at least one opening for thelateral malleolus and wherein the first portion of the web includes atleast one opening for the medial malleolus.

The invention relates to the previously described ankle brace whereinthe elastomeric material is a thermoplastic elastomer having a Shore Ahardness of 5-95 at 10 sec when measured in accordance with ASTM D2240or a tensile break at stretch of 2-6 MPa at 23° C. using Die C2 hourwhen measured in accordance with ASTM D412 or a tensile stress of 0.08to 0.8 MPa at strain 100% and 0.2 to 1.5 MPa at 300% at 23° C. using DieC2 hour when measured in accordance with ASTM D412 or an Elongation atbreak of 800-1200% at 23° C. using Die C2 hour when measured inaccordance with ASTM D414 or a tear strength of 7.5-20 kN/m whenmeasured in accordance with ASTM D624 or a compression set of 5-30% at23° C. and at Time 79200 sec when measured in accordance with ASTM D395where the elastomeric material could be a elastomeric material is athermoplastic elastomer sold under the trademarks Versaflex CL30, andCL2000X from PolyOne including such an elastomeric material compoundedwith an additional materials selected from the group comprising otherelastomers, cross-linking agents, reinforcing fibers and fillers,antimicrobial agents, colorants, and fragrances, and in particularwherein the reinforcing fiber is selected from glass, steel and carbonfiber. And this ankle brace could be formed by molding or casting.

The ankle brace also relates to an ankle brace for a hypothetical userhaving a leg including an ankle joint complex below a gastrocnemius atthe proximal side and behind the neck of a fifth metatarsal on thedistal side, the brace comprising a sleeve formed of a web ofbiocompatible elastomeric material having a through thickness of from 1to 7 mm, and a that has a first portion which forms a first continuousloop about a first axis and a second portion that forms a secondcontinuous loop about a second axis; and the first portion of the webhaving a proximal end which includes a top opening sized to fit belowthe belly of the gastrocnemius of the hypothetical user and the distalend of the first portion being connected to the proximal end of thesecond portion at a conjunction of the first portion and the secondportion, and the distal portion of the second portion including a bottomopening sized to fit posterior to the neck of the fifth metatarsal ofthe hypothetical user; and the web including at least a firstfenestration at the conjunction of the first and the second portions andthe ankle brace further comprising a removable support member whichprovides resistance to a force applied to the anterior tibiofibularligament.

The invention in particular relates to a brace, including an athleticsupport or orthopedic brace which include an elastomeric hinge. Thehinge is provided by having a ringed or looped support member thatincludes a section of reduced rigidity, for example, by changing thematerial characteristics, such as by lower cross-linking or by reducingthe volume of the support for a section. In FIG. 5, the hinge section isshown at 200 and extends from an anterior edge 202 to a posterior edge204. This section is thinner in cross section as s shown in the detailsshown in FIGS. 10-12. In particular, the edge-on view from FIG. 11illustrates that the support generally stands from 0.15 0.01 to 0.15inches, and preferably from 0.25 to 0.12, and most preferably from 0.3to 0.8 inches or roughly 0.06 inches above the web of material, but inthe hinge section 200 the thickness is from 25% to 75% and preferablyfrom 30% to 70%, and more preferably from 40% to 60% or roughly half ofthat amount or 0.03 inch in thickness. Similarly, the width of the bandcan be reduced so long as the band remains thick enough in the hingesection that it does not become uncomfortable. In this instance, thereduced volume section is located at the bottom section of the hub sothat this area will expand to allow for the hinging action of the brace.In addition, there are two malleoli supports that oppose each other andwhich have similar hinge sections to define the axis of rotation of thehinge assembly as an axis that extends through the supports. The hingesections could also comprise break in the loops or notched sections, aswell as thinner sections, and the band could have opposing section topand bottom at 180° to allow the hinge to elongate relative to eachother.

F1G. 13 illustrates a first embodiment of an additional support member400 that extends from the plantar surface of the brace where two armsmembers are attached, such as by Velcro to the surface and the supportextends vertically upward in an arm 402 that attaches, such as by Velcro404 to the upper side of the leg portion of the brace. FIGS. 16 through18 illustrate another lateral support member 500 that again has two armsseparated by an arch and that attach by Velcro to the plantar surface ofthe brace and further having an arm that spirals over the top of thefoot to attach at a medial aspect of the brace by Velcro 504. FIG. 19through 21 illustrate an embodiment of the brace 10 having a differentadditional medial support member 600, which attaches to the bottomsurface of a wedge plate 610 and for which an arm 602 wraps over thefront of the ankle and attaches such as by Velcro 604 at the rear of thebrace member, and has a second arm 606 that extends up the height of thebrace. This embodiment of the brace 10 includes a Y-shaped medialsupport 600 which attaches to a wedge shaped foot plate 610 that isthicker on the medial side and extends at an angle of from 2 to 10°across the width of the foot. In a fourth embodiment of the invention,the brace support assembly includes a strap 700 and wedge foot plate 710which is thicker on the lateral side of the foot and angle to a narrowerthickness across the foot, also at an angle of from 2 to 10° across thewidth of the foot, but in the opposite direction. The strap extendsacross the top of the foot and fastens on the brace 10, such as byVelcro and the footplate 710 is attached to the planar surface of thebrace, such as by Velcro, and the strap is held to the bottom surface ofthe footplate such as by Velcro, and in fact, the footplate preferablyincludes recesses so that the strap is flush to the bottom of thefootplate.

While in accordance with the patent statutes the best mode and preferredembodiment have been set forth, the scope of the invention is notlimited thereto but rather by the scope of the attached claims.

What is claimed is:
 1. An ankle brace which supports the foot, ankle andleg of a user and comprising an interlinking network of band membersforming a first portion and a second portion, the first portion having adistal band which forms at least 200 degrees of an arc and the secondportion having a proximal band and a medial malleolus support and alateral malleolus support which together define a transverse axisextending between the medial malleolus support and the lateral malleolussupports, and a recess which accommodates the heel of the foot of theuser, and the interlinking network of bands further comprising a medialmid-toot band which extends from the medial malleolus support to thedistal band and a lateral mid-toot band which extends from the lateralmalleolus support to the distal band and a medial lower leg band whichextends from the medial malleolus support to the proximal band and alateral lower leg band which extends from the lateral malleolus supportto the proximal band wherein at least one support chosen from the medialmalleolus support and the lateral malleolus support has a section ofreduced rigidity which support encourages the interlinking network toform a hinge about the transverse axis to allow pivoting motion betweenthe first portion and the second portion but the network inhibitslateral and medial translational or pivotal motion about an axisperpendicular to the transverse axis along the length of the footbetween the first portion and the second portion.
 2. An ankle brace asset forth in claim 1, wherein brace has a rear entry.
 3. An ankle braceas set forth in claim 2, wherein the rear entry comprises an open areaof the second portion having a lateral portion, and an open area of thesecond portion having a medial portion contiguous to a medial closuremember that extends proximally and laps over the lateral portion of thesecond portion and including a closure member that fastens the medialclosure member about the ankle on the brace and the lateral portion ofthe second portion including a lateral closure member including aclosure member that fastens the lateral closure member about the ankle.4. An ankle brace as set forth in claim 1, wherein the section ofreduced rigidity comprises a section of reduced volume of material. 5.An ankle brace as set forth in claim 4, wherein the section of reducedvolume of the support comprises an area of reduced thickness or reducedwidth.
 6. An ankle brace as set forth in claim 5, wherein the section ofreduced volume comprises a gap or notch.
 7. An ankle brace as set forthin claim 1, wherein the section of reduced rigidity comprises a sectionof a material having increased elasticity.
 8. An ankle brace as setforth in claim 7, wherein the section of material having increasedelasticity comprises a section that has a lower cross-linking than theremainder of the support.
 9. An ankle brace as set forth in claim 1wherein both the medial malleolus support and the lateral malleolussupport have a section of decreased rigidity.
 10. An ankle brace as setforth in claim 1, wherein brace is formed by molding or casting.
 11. Anankle brace as set forth in claim 1, wherein the brace comprises theinterlinking network and an elastomeric web and the interlinking networkcomprises a material of a durometer that is 10 to 90 points higher onthe Shore A scale than the material of the elastomeric web.
 12. A bracecomprising an interlinking network of elastomeric band members having athickness of from 1 mm to 10 mm, a width of from 3 mm to 20 mm, and adurometer of from 10 to 140 on the Shore A scale, and forming a firstportion and a second portion, the first portion having a distal band andthe second portion having a proximal band and a medial support and alateral support which together define a transverse axis extendingbetween the medial support and the lateral support, and the interlinkingnetwork of bands further comprising a medial first portion band whichextends from the medial support to the distal band and a lateral firstportion band which extends from the lateral malleolus support to thedistal band and a medial second portion band which extends from themedial support to the proximal band and a lateral lower hand whichextends from the lateral support to the proximal band wherein either themedial support or the lateral support or both have a section ofdecreased rigidity so that the support together with the interlinkingnetwork forms a hinge about the transverse axis to allow pivoting motionbetween the first portion and the second portion.
 13. An ankle brace asset forth in claim 12, wherein the network includes linking members thatact as stiffening ribs in the anatomic orientation of the lateralcollateral ligamentous complex of the joint.
 14. An ankle brace as setforth in claim 12, wherein the distal band is a fiat band of materialhaving a durometer of from 40 to 100 on the Shore A scale which includesan interruption of a length along the long axis of the band and at afirst end and a second end joined by a gusset and the gusset is formedby a member which joins the first end and the second end of the band bya length which is longer than the length of the interruption.
 15. Anankle brace as set forth in claim 12, wherein the proximal band includesa closure mechanism that allows the size of the proximal opening to beadjusted.
 16. An ankle brace as set forth in claim 12, wherein the bracecomprises a biocompatible elastomeric material is tacky to the touch.17. A brace for a joint having a fr framework of support extendingbetween a first proximal opening and a second distal opening, whereinthe framework includes a first anchor at the first proximal openingcomprising a band that forms a closed loop for a proximal side of thejoint and a second anchor at the second distal opening comprising aclosed loop for the second side of the joint and a plurality of strutsextending radially from an elastomeric hinge comprising a loop having asection of reduced rigidity and operatively connected between the firstanchor and the second anchor and the struts comprising strips having athickness of from 1 to 4 mm and a width of from 3 to 10 mm and comprisedof a material having a durometer of 60 to 80 on the Share A scale andthe framework defines fenestrations which include webs of sheet materialcomprised of an elastomeric material having a durometer of 25 to 45 onthe Shore A scale and a stickiness of 000.5 to 30 N/100 in accordancewith ASTM peel strip test 3330D at 90°.
 18. An ankle brace as set forthin claim 17, wherein the second anchor is a band that forms a flat ringin the distal area of the closed loop and the flat ring includes aninterruption joined by a v-shaped member that opposes but also allowsthe expansion of the ring so as to form a snug fit with the user at thesecond opening.
 19. A brace for a joint having a framework of supportextending between a first proximal opening and a second distal opening,wherein the framework includes a first anchor at the first proximalopening comprising a band that forms a closed loop for a proximal sideof the joint and a second anchor at the second distal opening comprisinga closed loop for the second side of the joint and elastomeric bandsextending from a central loop having a section of reduced volume so asto allow the loop to flex in a directed manner and the elastomeric bandsextending from the central loop and connecting the first anchor and thesecond anchor and comprising strips having a width of from ¼ to ⅕ of aninch, wherein the first anchor and the second anchor is comprised of amaterial having a durometer of 60 to 50 on the Share A scale and athickness of to 10 mm, and the framework defines fenestrations whichinclude webs of sheet material comprised of an elastomeric materialhaving a durometer of 25 to 45 on the Shore A scale and a stickiness of000.5 to 30 N/100 in accordance with ASTM peel strip lest 3330D at
 9020. An ankle brace as set forth in claim 19, wherein the loop is a bandthat forms a flat ring and the section of reduced volume is a sectionhaving a reduced thickness or reduced width or both.